Cinnarizine vs. topiramate for migraine prophylaxis in children: a randomized, double-blind, parallel-group clinical trial
Abstract
Objectives: Migraine is a common and disabling neurological disorder in children, often requiring preventive treatment. This study aimed to compare the efficacy and tolerability of cinnarizine and topiramate in the prophylaxis of migraine in children and adolescents.
Materials and methods: In this randomized, double-blind, parallel-group clinical trial, 96 children aged 6-15 years with a diagnosis of migraine according to the International Classification of Headache Disorders (ICHD-3) [1], including both migraine with and without aura, without restriction to specific subtypes were enrolled. Participants were randomly assigned to receive either cinnarizine (25 mg once daily) or topiramate (25 mg once daily) for 12 weeks. Migraine attack frequency and severity were recorded using headache diaries at baseline, one month, and three months after treatment initiation. The primary outcome was the change in monthly migraine attack frequency. Secondary outcomes included changes in headache severity and the occurrence of adverse events. Between-group comparisons were performed using the Mann-Whitney U test, and within-group changes over time were analyzed using the Friedman test.
Results: Both cinnarizine and topiramate significantly reduced monthly migraine attack frequency and headache severity over the 12-week treatment period (P < 0.001 for within-group comparisons). At three months, the median number of migraine attacks decreased to two attacks per month in both groups, with no…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 96 participants or records.
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